CA2836405C - Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale - Google Patents

Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale Download PDF

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Publication number
CA2836405C
CA2836405C CA2836405A CA2836405A CA2836405C CA 2836405 C CA2836405 C CA 2836405C CA 2836405 A CA2836405 A CA 2836405A CA 2836405 A CA2836405 A CA 2836405A CA 2836405 C CA2836405 C CA 2836405C
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Prior art keywords
testosterone
gel
testosterone gel
intranasal
intranasal testosterone
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CA2836405A1 (fr
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Wayne KREPPNER
Siobhan Fogarty
Werner Oberegger
Paul Jose Pierre Marie Maes
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Acerus Biopharma Inc
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Acerus Biopharma Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10Drugs for genital or sexual disorders; Contraceptives for impotence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26Androgens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pregnancy & Childbirth (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)

Abstract

L'invention concerne des gels intranasaux de testostérone permettant une libération prolongée de testostérone dans la circulation systémique d'hommes et de femmes pour obtenir des taux sanguins efficaces constants de testostérone, sans induire de pic de testostérone non voulu dans les taux sanguins suite à l'administration pernasale. Les gels intranasaux de testostérone selon l'invention sont sans danger, pratiques à utiliser, bien tolérés, stables et peuvent être fabriqués facilement et reproductible à grande échelle. En outre, puisque les taux sanguins de testostérone supra-normaux et sous-normaux sont supposés être sensiblement maintenus à un minimum ou empêchés, et que les taux sériques de testostérone sont supposés rester sensiblement constants pendant la vie de la dose, c'est-à-dire que les gels intranasaux de testostérone selon l'invention permettent d'imiter les taux de testostérone physiologiques quotidiennement rythmiques normaux ou de restaurer les taux sanguins de testostérone à des taux de testostérone physiologiques quotidiennement rythmiques normaux, ces nouveaux gels conviennent, de manière unique, à une thérapie de remplacement de testostérone ou d'apport d'un complément de testostérone, et pour traiter efficacement des hommes chez qui on a diagnostiqué par exemple une déficience en testostérone, comme une faible libido sexuelle, un faible désir sexuel, une faible activité sexuelle, une faible fertilité, une faible spermatogenèse, une aspermatogenèse, une dépression et/ou un hypogonadisme, et des femmes chez qui on a diagnostiqué une dysfonction sexuelle, comme une faible libido sexuelle, un faible désir sexuel, une faible activité sexuelle, une faible réactivité du noyau amygdalien, une faible stimulation sexuelle, un trouble du désir sexuel hypo-actif (HSDD), un trouble de l'excitation sexuelle et/ou une anorgasmie. L'invention concerne également des méthodes et des applicateurs sans air multi-doses pré-remplis destinés à une administration pernasale des gels nasaux de testostérone selon l'invention.
CA2836405A 2011-05-15 2012-05-15 Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale Active CA2836405C (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3034552A CA3034552C (fr) 2011-05-15 2012-05-15 Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161486324P 2011-05-15 2011-05-15
US61/486,324 2011-05-15
US201161486634P 2011-05-16 2011-05-16
US61/486,634 2011-05-16
PCT/IB2012/001127 WO2012156822A1 (fr) 2011-05-15 2012-05-15 Gels nasaux de testostérone à libération prolongée, méthodes associées et systèmes applicateurs multi-doses pré-remplis destinés à une administration pernasale

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3034552A Division CA3034552C (fr) 2011-05-15 2012-05-15 Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale

Publications (2)

Publication Number Publication Date
CA2836405A1 CA2836405A1 (fr) 2012-11-22
CA2836405C true CA2836405C (fr) 2021-09-07

Family

ID=46579248

Family Applications (3)

Application Number Title Priority Date Filing Date
CA2836398A Active CA2836398C (fr) 2011-05-15 2012-05-15 Formulations intranasales bio-adhesives de gel de testosterone et leur utilisation pour traiter l'hypogonadisme chez les hommes
CA3034552A Active CA3034552C (fr) 2011-05-15 2012-05-15 Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale
CA2836405A Active CA2836405C (fr) 2011-05-15 2012-05-15 Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale

Family Applications Before (2)

Application Number Title Priority Date Filing Date
CA2836398A Active CA2836398C (fr) 2011-05-15 2012-05-15 Formulations intranasales bio-adhesives de gel de testosterone et leur utilisation pour traiter l'hypogonadisme chez les hommes
CA3034552A Active CA3034552C (fr) 2011-05-15 2012-05-15 Gels nasaux de testosterone a liberation prolongee, methodes associees et systemes applicateurs multi-doses pre-remplis destines a une administration pernasale

Country Status (16)

Country Link
EP (3) EP2709588B1 (fr)
JP (9) JP6152092B2 (fr)
KR (9) KR20200028503A (fr)
CN (4) CN110613679A (fr)
AR (2) AR086409A1 (fr)
AU (11) AU2012257492A1 (fr)
BR (2) BR112013029332A2 (fr)
CA (3) CA2836398C (fr)
DK (1) DK2714006T3 (fr)
EA (1) EA201391701A1 (fr)
ES (1) ES2859784T3 (fr)
IL (2) IL229401A0 (fr)
MX (4) MX2020008599A (fr)
PL (1) PL2714006T4 (fr)
WO (2) WO2012156822A1 (fr)
ZA (2) ZA201309264B (fr)

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Publication number Publication date
KR20190117803A (ko) 2019-10-16
JP2022105175A (ja) 2022-07-12
JP2014515038A (ja) 2014-06-26
KR20190006194A (ko) 2019-01-17
KR20230041081A (ko) 2023-03-23
IL229400A0 (en) 2014-01-30
JP2020073469A (ja) 2020-05-14
EA201391701A1 (ru) 2014-04-30
JP2021001206A (ja) 2021-01-07
CN103796636B (zh) 2019-04-05
AU2019203067A1 (en) 2019-05-23
KR20210029849A (ko) 2021-03-16
JP2022078222A (ja) 2022-05-24
CA2836405A1 (fr) 2012-11-22
AU2020267162B2 (en) 2022-06-09
JP7017254B2 (ja) 2022-02-08
KR20200118228A (ko) 2020-10-14
KR20140045400A (ko) 2014-04-16
PL2714006T3 (pl) 2021-08-16
MX2013013369A (es) 2014-10-17
MX2013013388A (es) 2014-09-15
CA3034552A1 (fr) 2012-11-22
CA3034552C (fr) 2023-02-07
JP2014513716A (ja) 2014-06-05
WO2012156820A9 (fr) 2014-02-20
EP2714006B1 (fr) 2020-12-09
AU2024216312A1 (en) 2024-10-24
AU2022202402A1 (en) 2022-05-12
WO2012156820A1 (fr) 2012-11-22
CN109481394B (zh) 2023-05-05
AU2019201618A1 (en) 2019-04-18
KR20200028503A (ko) 2020-03-16
AU2020267162A1 (en) 2020-12-03
MX2020008599A (es) 2022-08-31
IL229401A0 (en) 2014-01-30
PL2714006T4 (pl) 2021-08-16
BR112013029336A2 (pt) 2020-08-11
WO2012156822A1 (fr) 2012-11-22
AU2020210227A1 (en) 2020-08-20
EP2709588B1 (fr) 2021-08-25
JP6594924B2 (ja) 2019-10-23
JP2018199701A (ja) 2018-12-20
JP2020079257A (ja) 2020-05-28
CN103813784A (zh) 2014-05-21
MX363561B (es) 2019-03-27
JP6152092B2 (ja) 2017-06-28
KR20210135003A (ko) 2021-11-11
CA2836398C (fr) 2021-12-14
AR089553A1 (es) 2014-09-03
AU2012257490A1 (en) 2013-12-19
CN103796636A (zh) 2014-05-14
AU2017203470A1 (en) 2017-06-22
KR102088038B1 (ko) 2020-03-13
KR102568894B1 (ko) 2023-08-21
BR112013029336B1 (pt) 2021-11-30
MX2019003340A (es) 2019-07-04
AU2012257492A1 (en) 2013-12-19
BR112013029332A2 (pt) 2021-06-01
CA2836398A1 (fr) 2012-11-22
KR20140033408A (ko) 2014-03-18
AR086409A1 (es) 2013-12-11
EP2714006A1 (fr) 2014-04-09
DK2714006T3 (da) 2021-03-15
AU2017204182A1 (en) 2017-07-20
EP2709588A1 (fr) 2014-03-26
CN109481394A (zh) 2019-03-19
CN110613679A (zh) 2019-12-27
AU2019203400A1 (en) 2019-08-01
ZA201309264B (en) 2015-09-30
JP2017160204A (ja) 2017-09-14
ES2859784T3 (es) 2021-10-04
ZA201309265B (en) 2016-01-27
EP3977982A1 (fr) 2022-04-06

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